Trial Outcomes & Findings for Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection (NCT NCT05060003)
NCT ID: NCT05060003
Last Updated: 2024-02-20
Results Overview
-Defined as the proportion of ctDNA-positive participants having a ctDNA-negative test at Cycle 3 Day 1
TERMINATED
PHASE2
7 participants
Cycle 3 Day 1 (estimated to be 8 weeks)
2024-02-20
Participant Flow
Participant milestones
| Measure |
Unassigned Arm
-Participants were enrolled but not assigned to treatment arm.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Unassigned Arm
-Participants were enrolled but not assigned to treatment arm.
|
|---|---|
|
Overall Study
ctDNA negative
|
7
|
Baseline Characteristics
Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection
Baseline characteristics by cohort
| Measure |
Unassigned Arm
n=7 Participants
-Participants were enrolled but not assigned to treatment arm.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 3 Day 1 (estimated to be 8 weeks)Population: All participants enrolled did not start study treatment.
-Defined as the proportion of ctDNA-positive participants having a ctDNA-negative test at Cycle 3 Day 1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to end of treatment (estimated to be 12 months)Population: All participants enrolled did not start study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (estimated to be 48 months)Population: All participants enrolled did not start study treatment.
-Defined as the duration of time from the date of randomization to the date of earliest disease relapse or death, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (estimated to be 48 months)Population: All participants enrolled did not start study treatment.
-Defined as as the duration of time from the date of positive ctDNA being confirmed to the date of appearance of a distant metastasis or death, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (estimated to be 48 months)Population: All participants enrolled did not start study treatment.
-Defined as the duration of time from the date of positive ctDNA being confirmed to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment through 90 days after end of treatment (estimated to be 15 months)Population: All participants enrolled did not start study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment through completion of treatment (estimated to be 12 months)Population: All participants enrolled did not start study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (estimated to be 48 months)Population: All participants enrolled did not start study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (estimated to be 48 months)Population: All participants enrolled did not start study treatment.
Outcome measures
Outcome data not reported
Adverse Events
Unassigned Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Ansstas, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place